BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.25MM PLATE REDUCTION WIRE THRDD TIP W/SM STOP/150MM

    MDR report key: 2945492 · Received February 6, 2013

    Report

    Report Number
    2520274-2013-00805
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    December 7, 2010
    Report Date
    December 21, 2010
    Manufacturer
    SYNTHES
    Product Code
    HTY
    PMA / PMN Number
    K102694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED (B)(4) 2011. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION, NO FURTHER INFORMATION IS AVAILABLE ON THIS EVENT. NO FURTHER INVESTIGATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    (B)(6) REPORTED TWO PLATE REDUCTION WIRES BROKE WHILE INSERTING THEM. EACH WIRE WAS USED SEVERAL TIMES DURING ONE SURGERY. THE BREAKPOINT WAS BELOW THE STOP, SEE PICTURES ATTACHED. THEY HAD NO CHANCE TO REMOVE THE REDUCTION WIRE SINCE IT WAS BELOW THE BONE SURFACE. THE SURGEON CONFIRMED THAT THIS INCIDENT WOULD NO INFLUENCE ON THE PATIENT OUTCOME. THERE WAS THE FIRST BREAKAGE OF PLATE REDUCTION WIRES IN THE SERIES OF 6 DORSAL SURGERIES. THE HEAVY AESCULAP POWER DRILL MAY HAVE HAD A NEGATIVE INFLUENCE ON THE PLATE REDUCTION WIRE SINCE THE LOOSENING OF THE DRILL CHUCK COULD HAVE LED TO BENDING OF THE WIRE, WHICH FINALLY COULD HAVE LED TO THE BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50424 1.25MM PLATE REDUCTION WIRE THRDD TIP W/SM STOP/150MM 1.25MM PLATE REDUCTION WIRE HTY SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1